St. Jude Medical Initiates First U.S. Clinical Study of the EnligHTN Renal Denervation System

June 13, 2013

June 13, 2013 — St. Jude Medical Inc. announced U.S. Food and Drug Administration (FDA) approval to begin the EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure.

It is estimated that one in three American adults has hypertension, often referred to as high blood pressure — a condition that increases the risk of heart attack, stroke and kidney failure. Hypertension occurs when blood pressure in the arteries is elevated, requiring the heart to work harder than normal to circulate blood throughout the body.

“Sub-optimal blood pressure control is the most common attributable risk for death worldwide,” said William B. White, professor and chief of hypertension and clinical pharmacology in the Calhoun Cardiology Center at the University of Connecticut Health Center in Farmington and co-chair of the EnligHTN IV steering committee. “Despite the availability of several effective drugs, approximately 50 percent of patients have inadequately controlled blood pressure and eight to 12 percent are considered resistant to these medications. Renal denervation therapy may be an important advancement for these patients.”

Renal denervation is a minimally invasive therapy that may provide a lasting reduction in blood pressure for patients with hypertension who are resistant to medications. It is a specialized ablation procedure that targets nerves along the renal arteries leading to the kidneys. This intentional disruption of the nerves may cause a decrease in systolic and diastolic blood pressure.

A typical normal blood pressure is at or below 120 systolic and 80 diastolic, and is expressed as 120 / 80 mmHg. Hypertension is blood pressure greater than 140 / 90 mmHg. The risk of cardiovascular death is cut in half with every 20 mmHg decrease in systolic blood pressure.

William Gray, an interventional cardiologist at Columbia University Medical Center in New York City and co-chair of the EnligHTN IV steering committee stated, “The EnligHTN Renal Denervation System has shown tremendous promise in clinical studies outside the United States. We look forward to participating in this important study that has the real potential to change medical practice.”

The EnligHTN IV study is a randomized, single-blind, controlled, multi-center trial to demonstrate the safety and effectiveness of the EnligHTN Renal Denervation System in reducing systolic blood pressure when measured in an office setting. The study will enroll approximately 590 patients between the ages of 18 and 80 with an office systolic blood pressure of 160 mmHg or greater, who are taking three or more antihypertensive medications including a diuretic. Study patients will be enrolled at up to 80 sites in the U.S. and Canada.

“Researching the treatment of hypertension is one example of the ongoing investments St. Jude Medical is making to deliver high-quality, innovative products, such as the EnligHTN Renal Denervation System, which aim to reduce health care costs and improve patient outcomes,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “The EnligHTN IV study represents another important step in our commitment to advancing science, technology and clinical evidence that supports renal denervation for the millions of patients who live with uncontrolled high blood pressure.”